Product Details for: Ruconest
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
2100IU
Single-Dose Vial
351(a)
Ruconest
Rx
Proper Name
C1 Esterase Inhibitor (Recombinant)
C1 Esterase Inhibitor (Recombinant)
BLA Number
125495
125495
Applicant
Pharming Americas BV
Pharming Americas BV
Original Approval Date
July 16, 2014
July 16, 2014
Date of First Licensure
16-Jul-14
16-Jul-14